ACTRN12612000848808
Terminated
Phase 2
A Phase II study assessing the complete remission rate and overall survival of older patients with acute myeloid leukaemia and high risk myelodysplastic syndrome that undergo less intensive treatment
Australasian Leukaemia and Lymphoma Group0 sites60 target enrollmentAugust 13, 2012
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Acute myeloid leukaemia (AML)
- Sponsor
- Australasian Leukaemia and Lymphoma Group
- Enrollment
- 60
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Acute myeloid leukaemia (except Acute Promyelocytic Leukaemia) as defined by the WHO Classification. This can be any type of de novo or secondary AML – or high risk Myelodysplastic Syndrome (greater than 10% blasts, RAEB\-2\). MDS patients who have received azacitidine are not eligible for this trial, but patients with less than 10% who have failed a demethyation agent and developed AML may enter the trial.
- •2\.Over the age of 60
- •3\.Given written informed consent.
- •For the AC220 (quizartinib), tosedostat and ganetespib interventions:
- •4\.Cardiac criteria must be met
- •5\.Electrolyte levels of Potassium, Magnesium and Calcium (adjusted) must be within the institutional normal range
- •Male patients must use an effective barrier method of contraception if sexually active with a female of child\-bearing potential.
Exclusion Criteria
- •1\.Less than 60 years of age
- •2\.Previously received cytotoxic chemotherapy for AML (hydroxycarbamide, or similar low\-dose therapy, to control the white count is not an exclusion criterion. Previous treatment with a demethylating agent for MDS less than 10% blasts is not an exclusion).
- •3\.Blast transformation of chronic myeloid leukaemia (CML)
- •4\.Concurrent active malignancy under treatment
- •5\.Pregnant or lactating
- •6\.Acute Promyelocytic Leukaemia
- •7\.Known infection with human immunodeficiency virus (HIV)
- •8\.Total bilirubin greater than or equal to 1\.5 x ULN, unless due to Gilbert’s syndrome
- •9\.Aspartate aminotransferase (AST) greater than or equal to 2\.5 x UL and/or alkaline phosphatase greater than or equal to 2\.5 x ULN
- •10\.Serum creatinine greater than or equal to 175µmol/L
Outcomes
Primary Outcomes
Not specified
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